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| Name | Class |
|---|---|
| The Government Pharmaceutical Organization | OTHER_GOV |
| World Health Organization | OTHER |
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The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be given in both Phase I and Phase II of the study.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.
Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| an inactivated influenza vaccine | Active Comparator | 20 volunteers in phase I study and 200 volunteers in phase II study will receive a single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
|
| Placebo | Placebo Comparator | 20 volunteers in phase I study and 100 volunteers in phase II study will receive a single dose of placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| an inactivated influenza vaccine | Biological | The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Punnee Pitisuttithum, Prof. | Mahidol University | Principal Investigator |
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A total of 340 participants (40 in phase I and 300 in phase II) who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inactivated Influenza Vaccine Phase I | A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| FG001 | Placebo Phase I | A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| FG002 | Inactivated Influenza Vaccine Phase II | A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| FG003 | Placebo Phase II | A single dose of placebo (0.9% normal saline solution) was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Inactivated Influenza Vaccine Phase I | A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine | All participants who receive at least one vaccination would be included in the safety population. The analysis will be conducted based on intent-to-treat (ITT) analysis. The population for the ITT analysis is defined as all individuals in the trial. The ITT analysis would include individuals who may not complete follow-up. | Posted | Count of Participants | Participants | 90 days |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inactivated Influenza Vaccine Phase I | Serious Adverse Event Phase I vaccine group N= 20 |
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No limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof.Punnee Pitisuttithum | Mahidol university | 662 6435599 | punnee.pit@mahidol.ac.th |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Other | The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
|
| Geometric Mean of Immune Response at Every Time of Assessment | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) | 90 days |
| Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II | 90 days |
| BG001 | Placebo Phase I | A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| BG002 | Inactivated Influenza Vaccine Phase II | A single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| BG003 | Placebo Phase II | A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis). | Count of Participants | Participants |
|
| Region of Enrollment | Phase I: N=40 participants, Phase II: N = 300 participants | Count of Participants | Participants | No |
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Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20) |
| OG002 | Inactivated Influenza Vaccine Phase II | Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200) |
| OG003 | Placebo Phase II | Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100) |
|
|
| Secondary | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40. | Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT). | Posted | Count of Participants | Participants | 90 days |
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|
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| Secondary | Geometric Mean of Immune Response at Every Time of Assessment | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) | The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT). | Posted | Geometric Mean | 95% Confidence Interval | titer | 90 days |
|
|
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| Secondary | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II | The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT). | Posted | Geometric Mean | 95% Confidence Interval | titer | 90 days |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo Phase I | Serious Adverse Event Phase I placebo group N= 20 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Inactivated Influenza Vaccine Phase II | Serious Adverse Event Phase I vaccine group N= 200 | 0 | 200 | 0 | 200 | 0 | 200 |
| EG003 | Placebo Phase II | Serious Adverse Event Phase I placebo group N= 100 | 0 | 100 | 0 | 100 | 0 | 100 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/H1N1 Day 60 |
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| A/H1N1 Day 90 |
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| A/H3N2 day 21 |
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| A/H3N2 Day 60 |
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| A/H3N2 Day 90 |
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| B/Brisbane/60/2008 Day 21 |
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| B/Brisbane/60/2008 Day 60 |
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| B/Brisbane/60/2008 Day 90 |
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| A/H1N1 Day 21 |
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| A/H1N1 Day 60 |
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| A/H1N1 Day 90 |
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| A/H3N2 Day 0 |
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| A/H3N2 Day 21 |
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| A/H3N2 Day 60 |
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| A/H3N2 Day 90 |
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| B/Brisbane/60/2008 Day 0 |
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| B/Brisbane/60/2008 Day 21 |
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| B/Brisbane/60/2008 Day 60 |
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| B/Brisbane/60/2008 Day 90 |
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| A/H1N1 Day 60 |
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| A/H1N1 Day 90 |
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| A/H3N2 day 21 |
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| A/H3N2 Day 60 |
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| A/H3N2 Day 90 |
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| B/Brisbane/60/2008 Day 21 |
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| B/Brisbane/60/2008 Day 60 |
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| B/Brisbane/60/2008 Day 90 |
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